Bone fixation system

ABSTRACT

An implant for fixation of a bone includes a shaft having a proximal end and a distal end, and a longitudinal axis defined between the proximal end and the distal end. A plurality of blades are disposed on the shaft, and are helically twisted about the longitudinal axis. At least one of the blades has a variable blade width that increases in a direction along the longitudinal axis. A mechanism for coupling the implant to a second fracture fixation implant may be provided separately or in combination.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application is a divisional of U.S. application Ser.No. 09/978,002, filed Oct. 17, 2001.

FIELD OF THE INVENTION

[0002] The present invention relates generally to a system for fixationof two or more parts of a fractured bone. More specifically, the presentinvention relates to a bone implant and locking apparatus for internalfixation of a long bone, such as a femur.

BACKGROUND OF THE INVENTION

[0003] Fractures commonly occur in the femur, and especially in thefemoral neck and intertrochanteric regions. Traditionally, thesefractures have been treated using a nail located in the femoral head incooperation with a side plate located on the outside of the femur, or incooperation with an intramedullary nail located in the intramedullarycanal. The nail cooperates with the side plate or intramedullary nail toalign and compress the bone fragments.

[0004] A high incidence of death is associated with hip fractures due tothe injury itself or related complications. Frequent complications mayarise when two or more bone fragments are forced towards each other whenthe patient supports his or her weight on the healing bone. For example,a sharp implanted nail or hip screw may cut through and penetrate thefemoral head or neck; or a nail, hip screw, side plate, orintramedullary nail may bend or break under load where the contactbetween bone fragments is insufficient for the bone itself to carry thepatient's weight.

[0005] A variety of compressible fixation systems have been developed tomaximize bone to bone contact while permitting bone fragments to migratetowards one another. For example, helical blades have been developedthat may be inserted into and secured to the neck of a femur, andcoupling mechanisms have been developed to slidably couple the helicalblade to a side plate or intramedullary nail.

[0006] The prior art blades, however, may be susceptible to migrationwithin the bone fragment and, even worse, may break free or pull out ofthe bone fragments, thus allowing the bone fragments to separate and/orbecome misaligned. Prior art blades are also susceptible to bendingstresses, which may lead to undesirable bending or breakage of theblade.

[0007] In addition, many prior art coupling mechanisms provide unlimitedamounts of sliding between the blade and the side plate orintramedullary nail, which may lead to disassembly of the blade and sideplate/intramedullary nail. Furthermore, prior art coupling mechanism areoften complicated and difficult to assemble during implantation.

[0008] Thus, a need exists for improved bone fixation systems.

SUMMARY OF THE INVENTION

[0009] The present invention is directed to bone fixation systemincluding implants and coupling mechanisms for fixation of a bone.According to one aspect of the invention, an implant for fixation of abone includes a shaft having proximal and distal ends and defines alongitudinal axis between the proximal and distal ends. A plurality ofblades, each having proximal and distal ends, are disposed on the shaftand are helically twisted about the longitudinal axis. According to oneembodiment, the plurality of blades may twist about 90° around thelongitudinal axis. At least one of the blades may have a variable bladewidth that varies along the longitudinal axis. For example, the variableblade width may increase in a direction from the blade proximal endtoward the blade distal end. Additionally or alternatively, at least oneof the blades may have a variable blade height that varies along thelongitudinal axis. For example, the variable blade height may increasein a direction from the blade proximal end toward the blade distal end.The variable blade height is preferably substantially zero at the bladeproximal end, such that the proximal end of the blade is substantiallyflush with the proximal end of the shaft.

[0010] According to a further aspect of the invention, the shaft of theimplant may define a bladed portion and a non-bladed portion. Thenon-bladed portion may define a non-bladed diameter, and the bladedportion may define a bladed diameter that is smaller than the non-bladeddiameter. In addition, the non-bladed portion may include a taperedregion located substantially adjacent the bladed portion, wherein thetapered region defines a tapered region diameter that decreases in adirection toward the bladed portion. The tapered region may furtherdefine a neck diameter at a point substantially adjacent the blades thatis smaller than the blade diameter.

[0011] The present invention is also directed to a coupling mechanismfor coupling a first fracture fixation implant to a second fracturefixation implant. The coupling mechanism includes a body memberreceivable in the first implant and including a single prong extendingfrom the body for contacting a surface of the second implant. Thecoupling mechanism further includes a drive member rotatably coupled tothe body member for threadable engagement with the first implant. Thedrive member rotates freely with respect to the body member and may beused to urge the body member toward the second implant such that thesingle prong contacts the surface of the second implant andsubstantially prevents rotation of the second implant with respect tothe first implant. More specifically, the single prong may define afirst engagement surface, the second implant may define a secondengagement surface, and the first and second engagement surfaces mayinteract to substantially prevent rotation of the second implant withrespect to the first implant.

[0012] According to a further aspect of the invention, the single prongmay limit sliding of the second implant with respect to the firstimplant. For example, the second engagement surface may include stopsformed adjacent at least one of its ends for contacting the prong toprevent further sliding of the second implant.

[0013] The coupling mechanism may also be provided in a system forfixation of a fractured bone, which includes first and second fracturefixation implants.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The detailed description will be better understood in conjunctionwith the accompanying drawings, wherein like reference charactersrepresent like elements, as follows:

[0015]FIG. 1 is a perspective view of one illustrative embodiment of afracture fixation system according to the present invention, shownimplanted in a femur;

[0016]FIG. 2 is a left side view of an illustrative embodiment of afracture fixation implant of FIG. 1;

[0017]FIG. 3 is a top view of the implant of FIG. 2, with portions shownin cross-section;

[0018]FIG. 4A is a front view of the implant of FIG. 2;

[0019]FIGS. 4B to 4F are cross-sectional views of the implant of FIG. 2,taken along lines B-B to F-F of FIG. 2, respectively;

[0020]FIG. 5 is a right side view of an illustrative embodiment of acoupling mechanism according to the present invention, shown inside thesecond fracture fixation implant of FIG. 1;

[0021]FIG. 6 is a right side view of the second implant of FIG. 5;

[0022]FIG. 7 is an enlarged, cross-sectional view of a portion of thesecond implant of FIG. 5;

[0023]FIG. 8 is a front view of a body member of the coupling mechanismof FIG. 5;

[0024]FIG. 9 is a left side view of the body member of FIG. 8, withportions shown in cross-section;

[0025]FIG. 10 is a right side view of the body member of FIG. 8;

[0026]FIG. 11 is a top view of the body member of FIG. 8;

[0027]FIG. 12A is a partial cross-sectional view of the couplingmechanism of FIG. 5;

[0028]FIG. 12B is a partial cross-sectional view of an alternativeembodiment of the coupling mechanism of FIG. 5, including a two-prongedbody member;

[0029]FIG. 13 is a perspective view of a drive member of the couplingmechanism of FIG. 5;

[0030]FIG. 14 is a cross-sectional view of the drive member of FIG. 13;

[0031]FIG. 15 is right side view of an end cap of the second implant ofFIG. 6;

[0032]FIG. 16 is a back view of the end cap of FIG. 15;

[0033]FIG. 17 is a perspective view of an illustrative embodiment of aninsertion handle for use with an implant system according to the presentinvention; and

[0034]FIG. 18 is a perspective view of the insertion handle of FIG. 17,shown coupled to the second implant of FIG. 6.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] Referring to FIG. 1, a fracture fixation implant 20 according toone embodiment of the present invention is shown implanted in a femurand coupled to a second fracture fixation implant 22, which is shown forillustrative purposes as an intramedullary nail 22. Implant 20 may beused in conjunction with an intramedullary nail 22 or other fracturefixation member to treat orthopaedic trauma, impending bone fractures,and bone fractures. For example, implant 20 may be used to treatintertrochanteric fractures of the femur. Implant 20 is not limited touse in conjunction with an intramedullary nail 22, however, and may beused alone or in conjunction with any number of implants, bone plates,etc., known to one of ordinary skill in the art. Furthermore, thepresent invention is not limited to treatment of the femur, and may beused to treat any of the bones in the human and/or animal bodies.

[0036] Referring to FIGS. 2 and 3, implant 20 includes a shaft 24 havinga proximal end 26 and a distal end 28, and defines a longitudinal axis30 between the proximal and distal ends 26, 28. A plurality of blades 32are disposed on shaft 24 and are helically twisted about longitudinalaxis 30, as will be discussed in more detail below. The plurality ofblades 32 has a proximal end 34 and a distal end 36, and blade proximalend 34 is preferably located substantially adjacent shaft proximal end26. Blades 32 may alternatively be located on shaft 24 at anintermediate position between shaft proximal and distal ends 26, 28.

[0037] A cannulation 38 (shown in FIG. 3) may optionally be provided inshaft 24 and oriented substantially coaxially with longitudinal axis 30.If provided, cannulation 38 may be sized to permit insertion of a guidewire (not shown) to aid in the alignment of implant 20 during theimplantation procedure, as is commonly known in the art. Shaft distalend 28 may be configured and dimensioned for attachment to an insertiondevice (not shown), such as an insertion handle or driving cap. Forexample, as shown in FIGS. 2 and 3, shaft distal end 28 may be angledwith respect to shaft longitudinal axis 30 and/or include a recess 35having a threaded portion 37 for attachment to an insertion device. Asbest seen in FIG. 1, recess 35 may have a non-symmetrical shape, such asa D-shape, so that the rotational orientation of implant 20 can bereadily ascertained from distal end 28.

[0038] Referring to FIGS. 4A-4F, implant 20 is preferably provided withfour helical blades 32 a-32 d that twist about longitudinal axis 30. Oneof ordinary skill in the art will know and appreciate, however, thatimplant 20 may be provided with any number of blades 32, such as five,six, or eight blades. Blades 32 a-32 d each have a helical twist aboutlongitudinal axis 30, which is shown as approximately 90°. Thus, eachblade is rotated approximately 90° about longitudinal axis betweenproximal end 34 (shown in FIG. 4A) and distal end 36 (shown in FIG. 4F).The helical twist is such that once implant 20 is driven into a bone,e.g., the femur, the helical twist of blades 32 substantially preventsimplant 20 from sliding in the bone along longitudinal axis 30. One ofordinary skill in the art will know and appreciate that blades 32 mayhave any amount of helical twist about longitudinal axis 30, such as,for example, 45°, 60°, 120°, 180°, 360°, 720°, or 1080°.

[0039] As shown in FIGS. 4A-4F, a first blade 32 a and a second blade 32c are substantially diametrically opposed from one another aboutlongitudinal axis 30, and a third blade 32 b and a fourth blade 32 d arealso substantially diametrically opposed from one another aboutlongitudinal axis 30. First and second blades 32 a, 32 c are preferablyabout 90° out of phase with respect to third and fourth blades 32 b, 32d, however other configurations are within the present invention.Preferably in one embodiment, at least one of the blades 32 defines ablade width W that varies along longitudinal axis 30. More specifically,blade 32 b has a blade width Wb that increases from blade proximal end34 (shown in FIG. 4A) to blade distal end 36 (shown in FIG. 4F), suchthat blade width Wb is greatest substantially adjacent blade distal end36 and smallest substantially adjacent blade proximal end 34.Preferably, blade width Wb gradually tapers outward from proximal end 34to distal end 36.

[0040] In the illustrative embodiment shown, blades 32 b and 32 d bothhave variable blade widths Wb and Wd, respectively. When implant 20 isin the intended rotational orientation within the bone, shown in FIG. 1,the distal ends 36 of blades 32 b and 32 d are substantially alignedwith the plane in which the majority of forces are applied to implant 20(a substantially vertical plane, in the view of FIG. 1, extendingthrough longitudinal axis 30 and longitudinal axis 68). Thus, thegreater widths Wb, Wd of blades 32 b, 32 d around distal ends 36increase the bending strength of implant 20, while the decreased widthsat proximal ends 34 provides for ease of insertion of implant 20 intothe bone. The taper of blades 32 b and 32 d also helps to preventsliding of implant 20 within the bone along longitudinal axis 30.

[0041] Additionally or alternatively, one or more of the blades 32 mayhave a substantially constant blade width W. For example, as shown inFIGS. 4A-F, blade 32 c may have a substantially constant width Wc thatis substantially equal at blade proximal end 34 (shown in FIG. 4A), atthe intermediate points shown in FIGS. 4B-4E, and at blade distal end 36(shown in FIG. 4F). In the illustrative embodiment shown, blade 32 aalso has a substantially constant blade width Wa (blade width Wa appearsto vary in FIGS. 4A-4F due to the variance in blade height Ha, discussedbelow, however blade width Wa is actually substantially constant alonglongitudinal axis 30).

[0042] According to a further aspect of the present invention, at leastone of the blades 32 may define a blade height H (definedperpendicularly to longitudinal axis 30 from the base of the blade 32 tothe tip of the blade) that varies along longitudinal axis 30. Inparticular, blade 32 a may have a blade height Ha that increases fromblade proximal end 34 (shown in FIG. 4A) to blade distal end 36 (shownin FIG. 4F), such that blade height Ha is greatest substantiallyadjacent blade distal end 36 and smallest substantially adjacent bladeproximal end 34. Preferably, blade height Ha is substantially zero atblade proximal end 34, as shown in FIG. 4A, such that blade 32 a issubstantially flush with shaft 24 at proximal end 34. When implant 20 isin the intended rotational orientation of FIG. 1, the decreased heightHa or substantially flush configuration of blade 32 a at proximal end 34increases the distance X implant 20 must migrate in the bone before itcuts completely through the bone. Also, the flush configuration of blade32 a at proximal end 34 reduces migration of implant 20 in the bone(because there is virtually no blade 32 a at proximal end 34 to cutthrough the bone when a load is applied).

[0043] Additionally or alternatively, at least one of the blades 32 mayhave a substantially constant blade height H. For example, as shown inFIGS. 4A-4F, blades 32 b, 32 c, and 32 d each have substantiallyconstant blade heights Hb, Hc, and Hd, respectively, that aresubstantially constant from blade proximal end 34 (shown in FIG. 4A)through the intermediate points shown in FIGS. 4B-4E, and at bladedistal end 36 (shown in FIG. 4F).

[0044] Referring back to FIG. 3, implant 20 includes a bladed portion40, upon which blades 32 are disposed, and a non-bladed portion 42 thatis without any blades 32. Bladed portion 40 defines a bladed diameter 44and non-bladed portion 42 defines a non-bladed diameter 46. The maximumdiameter of bladed portion 40 (i.e., where bladed diameter 44 is at itsgreatest) may preferably be smaller than the maximum diameter ofnon-bladed portion 42 (i.e., where non-bladed diameter 46 is at itsgreatest). According to this configuration of implant 20, bladed portion40 may pass freely through bore 66 in intramedullary nail 22 (shown inFIG. 5 and discussed in detail below) to provide ease of assembly, andnon-bladed portion 42 may mate with bore 66 to provide a stable slidinginterconnection between non-bladed portion 42 and bore 66.

[0045] Non-bladed portion 42 may be further provided with a taperedregion 48 located substantially adjacent the bladed portion 40. Taperedregion 48 defines a tapered region diameter 50 that decreases in adirection toward bladed portion 40. For example, tapered region diameter50 may, at the location adjacent to the untapered region, be equal tonon-bladed diameter 46 and decrease, or taper inward, along longitudinalaxis 30 towards the distal end of bladed portion 40. Preferably, taperedregion 48 is curved inwardly to provide even stress distributionthroughout the tapered region 48, and to provide a uniform bending ofimplant 20 under loading. Additionally or alternatively, tapered region50 may further define a neck diameter 52 at a point substantiallyadjacent bladed portion 40 (at the point where non-bladed portion 42meets bladed portion 40) that is smaller than bladed diameter 44. Thisconfiguration of implant 20 provides for bone ingrowth between thenon-bladed portion 42 and the bladed portion 40, thereby providingresistance against implant 20 from backing out of the bone. In addition,tapered region 48 serves to self-center implant 20 as implant 20 isinserted into bore 66 of intramedullary nail 22 (shown in FIG. 5).

[0046] The present invention is also directed to a mechanism which maybe used to couple a first fracture fixation implant 20 to a secondfracture fixation implant 22. As described herein, the couplingmechanism may be used to couple implant 20, described above, to anintramedullary nail 22. The coupling mechanism, however, is not limitedto use with implant 20 and/or intramedullary nail 22, and may be used tocouple any number of different fracture fixation implants known to thoseof ordinary skill in the art.

[0047] Referring to FIG. 5, a body member 60 and a drive member 62 areshown assembled into an interior channel 64 in intramedullary nail 22.Body member 60 and drive member 62 cooperate with channel 64 to secureimplant 20 (not shown) in a bore 66 that extends through intramedullarynail 22. As will be discussed in more detail below, body member 60,drive member 62 and channel 64 cooperate to substantially preventimplant 20 from rotating about its longitudinal axis 30 (shown in FIGS.1-3) within bore 66, and also to limit sliding of implant 20 within bore66 to a predetermined distance.

[0048] Referring to FIGS. 6 and 7, the configuration of intramedullarynail 22 is shown in detail. Intramedullary nail 22 defines alongitudinal axis 68 that may be straight, bent (shown), curved, orotherwise configured and dimensioned to mate with the geometry of thebone into which intramedullary nail 22 is to be implanted. Channel 64extends substantially along longitudinal axis 68, and is dimensioned andconfigured to receive body member 60 and drive member 62, such that thetwo parts may move in channel 64 at least partially along longitudinalaxis 68. A series of threads 98 may be disposed on channel 64, as willbe discussed in detail below. Also, a pair of grooves 65 may be formedon channel 64, and are preferably diametrically opposed from oneanother.

[0049] Still referring to FIGS. 6 and 7, bore 66 extends throughintramedullary nail 22 and intersects with channel 64, and isdimensioned and configured to allow implant 20 to slide therethrough.According to the illustrative embodiment shown, bore 66 is configuredand dimensioned to slidably engage non-bladed portion 42 of implant 20,and maintain implant 20 in angular relationship with respect tolongitudinal axis 68. As shown, bore 66 is disposed at an angle 70 withrespect to longitudinal axis 68. Angle 70 may be selected to match theanatomy of the patient in which intramedullary nail 22 and implant 20are to be implanted, for example, to correspond to the femoralneck/shaft angle of a human patient. A cannulation 72 (partially shownin FIG. 7) may optionally be provided through intramedullary nail 22 insubstantial coaxial alignment with longitudinal axis 68. If provided,cannulation 72 may be sized to permit insertion of a guide wire (notshown) to guide the implantation of intramedullary nail 22 into thebone, as is commonly known in the art.

[0050] Referring to FIGS. 8-11, body member 60 is shown in detail. Bodymember 60 includes a substantially cylindrical portion 78 that defines alongitudinal axis 80 of the body member 60, and a prong 76 extendingfrom cylindrical portion 78. One of ordinary skill in the art will knowand appreciate, however, that body member 60 is not limited to the shapeshown, and may have any shape that permits body member 60 to move withinchannel 64 of intramedullary nail 22. A pair of alignment tabs 85 (shownin FIGS. 8 and 11) may extend from cylindrical portion 78. If provided,tabs 85 are positioned on body member 60 such that tabs 85 may bereceived in grooves 65 (shown in FIG. 7) of intramedullary nail 22.Cooperation between tabs 85 and grooves 65 substantially limits rotationof body member 60 within channel 64 of intramedullary nail 22.

[0051] Cooperation between tabs 85 and grooves 65 also maintains surface79 (illustrated in FIG. 9) of body member 60 at a distance from implant20 when the coupling mechanism is assembled and locked, thus allowingimplant 20 to freely slide in bore 66. More specifically, grooves 65have ends 67 (shown in FIG. 7) that contact tabs 85 and prevent bodymember 60 from sliding any further towards bore 66. Ends 67 are locatedin channel 64 at locations such that tabs 85 contact ends 67 (to preventfurther movement of body member 60 towards bore 66) before surface 79contacts implant 20. As shown in the figures, surface 79 is preferablyoriented at an angle 81 with respect to longitudinal axis 80 that issubstantially equal to angle 70, although angle 81 may be different thanangle 70. According to the configuration where angle 81 is substantiallyequal to angle 70, angled surface 79 remains at a constant distance fromimplant 20 when the coupling mechanism is assembled and locked.

[0052] Body member 60 may also include an attachment portion 82, whichis configured and dimensioned to rotatably couple body member 60 todrive member 62, as will be discussed in more detail below. As shown inFIG. 8, attachment portion 82 includes a pair of upward-extending arms83 that define a pair of opposed channels 83 a for receiving a portionof drive member 62 therein. A cannulation 84 may optionally be providedthrough body member 60 in substantial coaxial alignment withlongitudinal axis 80 to permit insertion of a guide wire (not shown)therethrough.

[0053] Still referring to FIGS. 8-11, prong 76 extends away from bodymember 60 in a direction substantially parallel to longitudinal axis 80,and may be configured and dimensioned to contact implant 20 to limitsliding and rotation of implant 20 with respect to longitudinal axis 30(shown in FIG. 1). As will be discussed in more detail below, prong 76may be provided with a first engagement surface 86 that contacts asecond engagement surface 90 formed on implant 20 to substantiallyprevent rotation of implant 20 and limit sliding of implant 20, as willbe discussed in more detail below. According to alternative embodimentsof the present invention, body member 60 may be provided with two ormore prongs to contact two or more engagement surfaces formed on implant20. For example, a second prong may extend from body member 60 in thesame direction as prong 76, and may be diametrically opposed to prong 76about longitudinal axis 80 and substantially parallel to prong 76. Thetwo-pronged embodiment may be used, for example, with an implant 20having two diametrically opposed engagement surfaces. Alternatively, asingle-pronged embodiment may be used with an implant 20 having two ormore engagement surfaces.

[0054] Referring back to FIGS. 2 and 3, an exemplary embodiment ofsecond engagement surface 90 is shown formed on implant 20. According tothe embodiment shown, second engagement surface 90 is substantially flatand extends along longitudinal axis 30. First and second stops 92, 94may be located at opposite ends of locking second engagement surface 90.In the illustrative embodiment shown, second engagement surface 90 isrecessed into shaft 24 of implant 20, and stops 92, 94 are formed at theboundaries of the recessed surface. One of ordinary skill in the artwill know and appreciate, however, that other configurations ofengagement surface 90 and stops 92, 94, are within the presentinvention. For example, engagement surface 90 and/or stops 92, 94 mayalternatively be formed on or extend from shaft 24. Furthermore, asdiscussed above, implant 20 may alternatively be provided with two ormore second engagement surfaces 90, which may interact with a bodymember 60 having one, two or more prongs.

[0055] When implant 20 is received in bore 66 in intramedullary nail 22and body member 60 is located in channel 64 with tabs 85 bottomed out onends 67 of groves 65, prong 76 interacts with implant 20 tosubstantially prevent rotation of implant 20 about its longitudinal axis30. More specifically, prong 76 fits tightly in the space betweenchannel 64 and implant 20 such that first and second engagement surfaces86, 90 are maintained in contact under the constraints of channel 64. Inthis configuration, implant 20 is substantially prevented from rotationabout its longitudinal axis 30 due to abutment of substantially flatfirst and second engagement surfaces 86, 90. The coupling mechanism maythus be used to maintain implant 20 in its intended rotationalorientation within the bone. If provided, stops 92, 94 prevent implant20 and implant 22 from coming apart, and may also limit the amount ofsliding of implant 20 along its longitudinal axis 30 to the length ofsecond engagement surface 90. For example, once implant 20 slidesdistally until first stop 92 contacts prong 76, any further sliding inthe distal direction is prevented. Likewise, once implant 20 slidesproximally until second stop 94 contacts prong 76, any further slidingin the proximal direction is prevented. Thus, first and second stops 92,94 may be selectively spaced apart along longitudinal axis 30 to providefor a desirable amount of sliding between implant 20 and intramedullarynail 22, such as to provide for compression between the two fracturedbone fragments. For example, limited sliding may be desirable duringimplantation, to compress a fractured femur head toward the trochantericregion. Additionally, limited motion may also stimulate bone growth andfracture healing during service. One of ordinary skill in the art willknow and appreciate that first engagement surface 86 and secondengagement surface 90 are not limited to the substantially flatconfigurations shown herein. Rather, first and second engagementsurfaces 86, 90 may have any geometries that, when located adjacent oneanother, prevent rotation of implant 20 about axis 30, yet provide forsliding of implant 20 along longitudinal axis 30.

[0056] As discussed above, body member 60 may have two or more prongs76, and implant 20 may have two or more engagement surfaces 90. Whilemultiple prongs may be desirable in certain applications (such as whereextraordinarily large forces tend to rotate first implant 20 about itslongitudinal axis 30 with respect to second implant 22), the exemplaryembodiment having a single prong 76, shown in FIGS. 8-10, oralternatively having one prong longer than the other, provides forincreased ease of assembly over the two-pronged or multi-prongedembodiments having equal length prongs. For example, a single prong 76,or one prong longer than the other, may be advantageous in the instanceshown in FIG. 12A, where implant 20 is misaligned in bore 66 such thatfirst engagement surface 86 is misaligned with second engagement surface90. In this instance, movement of body member 60 toward implant 20causes prong 76 to slide along second engagement surface 90 to influenceimplant 20 to rotate about longitudinal axis 30 until first and secondengagement surfaces 86, 90 are flush with one another, and moreover, areengaged to substantially prevent rotation of implant 20. To thecontrary, when a two-pronged embodiment having equal length prongs, asshown in FIG. 12B, is moved toward an implant 20 that is misaligned inbore 66, one of the prongs 76 contacts shaft 24 and prevents the otherprong 76 from contacting the respective second engagement surface 90 torotate implant 20 into alignment. As shown, second prong 76 b is incontact with shaft 24 and prevents first prong 76 a from contactingsecond engagement surface 90 a to rotate implant 20 into properalignment with body member 60. Thus, a single-pronged embodiment (or amulti-pronged embodiment having one prong longer than the other) mayprovide for increased ease of assembly of the coupling mechanism.

[0057] Referring back to FIGS. 7, 8 and 11, tabs 85, if provided,cooperate with grooves 65 to substantially prevent body member 60 fromrotating within channel 64 of intramedullary nail 22. This provides theadvantage of aligning prong(s) 76 with engagement surface(s) 90 inchannel 64; thus, implant 20 can easily be inserted into bore 66 withoutrequiring the surgeon to address the alignment of prong(s) 76.

[0058] Referring to FIGS. 13 and 14, drive member 62 is shown in detail.Drive member 62 is configured and dimensioned to engage channel 64 toselectively hold body series of threads 96 which mate with a series ofthreads 98 formed in channel 64, however other structures for securingdrive member 62 in channel 64, such as springs or elastomers, are alsowithin the present invention. Drive member 62 also includes anattachment portion 100 which is configured and dimensioned to rotatablycouple drive member 62 to body member 60, such that drive member 62 mayfreely rotate with respect to body member 60. This is especially usefulin the case where tabs 85 (FIGS. 8 and 11) cooperate with grooves 65(FIG. 7) to prevent rotation of body member 60 in channel 64. In theexemplary embodiment shown, attachment portion 100 is a substantiallydisc-shaped flange that may be received between the channels 83 a formedin arms 83 of body member 60. One of ordinary skill in the art will knowand appreciate that any number of structures may alternatively beprovided to couple drive member 62 to body member 60 and provide forrotation between the two parts, such as, for example, screws, swivels,pins, etc. One of ordinary skill in the art will also know andappreciate that body member 60 and drive member 62 may be eitherpermanently attached, or detachably coupled to one another. Drive member62 may also include a tool-engaging portion 102. As shown, drive member62 defines a substantially hex-shaped opening 102 that is dimensionedand configured to engage a hex key. Tool-engaging portion 102 mayalternatively be dimensioned and configured to engage any number ofdriving tools known to one of ordinary skill in the art, such as a screwdriver or wrench. A cannulation 104 may optionally extend substantiallyaxially through drive member 62 to permit insertion of a guide wire (notshown) therethrough.

[0059] Referring to FIGS. 15 and 16, an optional end cap 106 is shown.End cap 106, if provided, may be removably attached to the end ofintramedullary nail 22 to conceal body member 60 and drive member 62 inchannel 64. In addition, in the case where the surgeon chooses not toengage the locking mechanism (e.g., does not tighten drive member 62 inchannel 64 in order to engage body member 60 with implant 20), end cap106 may be urged against drive member 62 to prevent drive member 62, andconsequently body member 60, from unintentionally migrating withinchannel 64.

[0060] In the illustrative embodiment shown in FIGS. 15 and 16, end cap106 includes a series of threads 108 disposed thereon, which mate withthe series of threads 98 formed on channel 64, or another series ofthreads formed on channel 64, to secure end cap 106 on intramedullarynail 22. Any number of structures known to one of ordinary skill in theart, including snap fasteners, adhesives or screws may alternatively beused to removably attach end cap 106 to intramedullary nail 22. End cap106 may further include a tool-engaging portion 110, shown as asubstantially hex-shaped portion 110 that is dimensioned and configuredto engage a wrench. Tool-engaging portion 110 may alternatively bedimensioned and configured to engage any number of driving tools knownto one of ordinary skill in the art, such as a hex-key or screw driver.A cannulation 112 may optionally be provided, which extendssubstantially axially through end cap 106 to permit insertion of a guidewire (not shown) therethrough.

[0061] Intramedullary nail 22 may be provided with body member 60, drivemember 62 and, optionally, end cap 106 preassembled into channel 64,thus reducing the amount of time associated with implantingintramedullary nail 22, as well as reducing the amount of parts thatmust be handled by the surgeon. In the case where these components arepreassembled, cannulations 72, 84, 104, and 112 (provided inintramedullary nail 22, body member 60, drive member 62, and cap 106,respectively) may be substantially aligned to permit insertion of aguide wire (not shown) completely through the preassembled unit. Thus, aguide wire may be used to guide intramedullary nail 22, including thepreassembled locking components, into the intramedullary canal of afractured bone.

[0062] As shown in FIGS. 17 and 18, an insertion handle 120 mayoptionally be provided to aid with insertion of the second implant(e.g., intramedullary nail 22). As shown, insertion handle 120 includesa handle portion 122 and a coupling portion 124. Coupling portion 124may include a bore 125 that is dimensioned and configured to receive acoupling screw 126. Coupling screw 126 may be inserted through bore 125and threaded into threads 98 of channel 64, to detachably coupleinsertion handle 120 to intramedullary nail 22. One of ordinary skill inthe art will know and appreciate, however, that other structures may beemployed to detachably couple insertion handle 120 to intramedullarynail 22. When attached to intramedullary nail 22, insertion handle 120may be used to aid insertion of intramedullary nail 22 into theintramedullary canal. A cannulation 128 may optionally be provided incoupling screw 126 and aligned with cannulations 72, 84, and 104(discussed above), to permit use of insertion handle 120 to insertintramedullary nail 22 over a guide wire. Furthermore, the length L ofcoupling screw 126, shown in FIG. 17, may be selected such thatinsertion handle 120 may be coupled to intramedullary nail 22 with bodymember 60 and drive member 62 preassembled therein.

[0063] While preferred embodiments and features of the bone implant andcoupling mechanism have been disclosed herein, it will be appreciatedthat numerous modifications and embodiments may be devised by thoseskilled in the art. It is intended that the appended claims cover allsuch modifications and embodiments as fall within the true spirit andscope of such claims and that the claims not be limited to or by suchpreferred embodiments or features.

What is claimed:
 1. An implant for fixation of a bone comprising: ashaft having a proximal end and a distal end, the shaft defining alongitudinal axis between the proximal end and the distal end; and aplurality of blades disposed on at least a portion of the shaft andhelically twisted about the longitudinal axis, the plurality of bladeshaving a proximal end and a distal end; wherein at least one of theblades has a variable blade width that varies in a direction along thelongitudinal axis.
 2. The implant of claim 1, wherein the variable bladewidth increases in a direction from the blade proximal end toward theblade distal end.
 3. The implant of claim 1, wherein at least one of theblades has a variable blade height that varies in a direction along thelongitudinal axis.
 4. The implant of claim 1, wherein at least one ofthe blades has a substantially constant blade width.
 5. The implant ofclaim 1, wherein the plurality of blades twist about 90° about thelongitudinal axis.
 6. The implant of claim 3, wherein the variable bladeheight increases in a direction from the blade proximal end toward theblade distal end.
 7. The implant of claim 3, wherein at least one of theblades has a substantially constant blade height.
 8. The implant ofclaim 1, wherein the plurality of blades comprises: at least first andsecond blades substantially diametrically opposed from one another aboutthe longitudinal axis; and at least third and fourth bladessubstantially diametrically opposed from one another about thelongitudinal axis; wherein at least one of the first and second bladeshas a variable blade width that increases in a direction along thelongitudinal axis, and at least one of the third and fourth blades has avariable blade height that increases in a direction along thelongitudinal axis.
 9. The implant of claim 6, wherein the blade heightof the variable blade is substantially zero at the blade proximal end.10. The implant of claim 9, wherein: at least one of the first andsecond blades has a substantially constant blade height; and at leastone of the third and fourth blades has a substantially constant bladewidth.
 11. The implant of claim 10, wherein: the first and second bladeshave a variable blade width that increases in a direction along thelongitudinal axis, and a substantially constant blade height; the thirdblade has a blade height that increases in a direction along thelongitudinal axis, and a substantially constant blade width; and thefourth blade has a substantially constant blade height, and asubstantially constant blade width.
 12. The implant of claim 11, whereinthe first and second blades are out of phase with the third and fourthblades by about 90° about the longitudinal axis.
 13. The implant ofclaim 1, wherein the implant is configured and dimensioned forimplantation in a femoral head.
 14. The implant of claim 1, furthercomprising a cannulation extending from the proximal end to the distalend, the cannulation configured and dimensioned to receive a guide wire.15. The implant of claim 1, wherein the distal end is configured anddimensioned for attachment to an insertion device.
 16. An implant forfixation of a bone comprising: a shaft defining a longitudinal axis ofthe implant, the shaft including a bladed portion and a non-bladedportion, the bladed portion and the non-bladed portion each having adiameter; a plurality of blades disposed on the bladed portion andhelically twisted about the longitudinal axis, wherein the maximumdiameter of the bladed portion is smaller than the maximum diameter ofthe non-bladed portion.
 17. The implant of claim 16, wherein thenon-bladed portion includes a tapered region located substantiallyadjacent the bladed portion, wherein the tapered region defines atapered region diameter that decreases in a direction toward the bladedportion.
 18. The implant of claim 17, wherein the tapered region isconfigured and dimensioned to provide even stress distribution over thetapered region.
 19. The implant of claim 17, wherein the tapered regionis concave.
 20. The implant of claim 17, wherein the tapered regionprovides uniform bending of the implant.
 21. The implant of claim 17,wherein the tapered region further defines a neck diameter at a pointsubstantially adjacent the blades, wherein the neck diameter is smallerthan the blade diameter.
 22. The implant of claim 17, wherein theimplant has proximal and distal ends located on the longitudinal axis,and the bladed portion is located substantially adjacent one of theends.
 23. The implant of claim 16, wherein the implant is configured anddimensioned for implantation in a femoral head.
 24. The implant of claim16, further comprising a cannulation extending substantially along thelongitudinal axis of the shaft, the cannulation configured anddimensioned to receive a guide wire.
 25. An implant for fixation of abone comprising: a shaft having a proximal end and a distal end, theshaft defining a longitudinal axis between the proximal end and thedistal end; and a plurality of blades disposed on at least a portion ofthe shaft and helically twisted about the longitudinal axis, theplurality of blades having a proximal end and a distal end; wherein atleast one of the blades has a variable blade height that varies in adirection along the longitudinal axis.
 26. The implant of claim 25,wherein the variable blade height increases in a direction from theblade proximal end toward the blade distal end.
 27. The implant of claim26, wherein the variable blade height is substantially zero at the bladeproximal end.
 28. The implant of claim 25, wherein at least one of theblades has a substantially constant blade height.
 29. The implant ofclaim 25, wherein at least one of the blades has a variable blade widththat varies in a direction along the longitudinal axis.
 30. The implantof claim 29, wherein the variable blade width increases in a directionfrom the blade proximal end toward the blade distal end.
 31. The implantof claim 25, wherein at least one of the blades has a substantiallyconstant blade width.
 32. The implant of claim 25, wherein the pluralityof blades twist about 90° about the longitudinal axis.
 33. The implantof claim 25, wherein the implant is configured and dimensioned forimplantation in a femoral head.
 34. The implant of claim 25, furthercomprising a cannulation extending from the proximal end to the distalend, the cannulation configured and dimensioned to receive a guide wire.35. The implant of claim 25, wherein the distal end is configured anddimensioned for attachment to an insertion device.